(68 days)
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No
The description focuses on the mechanical components and surgical technique of a bone nail, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as providing "temporary stabilization of various types of fractures," "compression and stabilization of the supracondylar fragments," and for procedures like "reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions." These functions are aimed at supporting the healing or structural integrity of bone, not directly treating a disease or condition for therapeutic purposes. It is an orthopedic implant for mechanical support.
No
The device is described as an implantable nail for stabilizing fractures and other bone procedures, not for diagnostic purposes.
No
The device description explicitly lists physical components made of titanium alloy (nails, screws, nut, set screw), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The Zeta MultiZone SCN Locking Nail is a surgical implant used to stabilize bone fractures. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes the device's function in providing temporary stabilization of bone fractures, which is a surgical procedure, not an in vitro diagnostic test.
Therefore, based on the provided information, the Zeta MultiZone SCN Locking Nail is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
Product codes
87HSB
Device Description
The Zeta MultiZone SCN Locking Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
distal femur, supracondylar region
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howmedica's SCN Nail, Depuy Ace's AIM Titanium Supracondylar Nail
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
OCT 21 1998
510(k) Summary
Zeta MultiZone SCN Locking Nail Proprietary Name: Common Name: IM Rod Intramedullary Fixation Rod Classification Name & 21 CFR 888.3020 Reference: Proposed Regulatory Class: II Device Product Code: 87HSB
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Zeta MultiZone SCN Locking Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade titanium alloy.
The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Howmedica's SCN Nail and Depuy Ace's AIM® Titanium Supracondylar Nail.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Ms. Vivian Kelly Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard -Rutherford, NJ 07070
Re: K982873 Zeta MultiZone SCN Locking Nail Trade Name: Requlatory Class: II Product Code: HSB August 13, 1998 Dated: Received: August 14, 1998
Dear Ms. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the origo or compitied, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications for Use
510(k) Number (if known): K982873
Device Name: Zeta MultiZone SCN Locking Nail
Indications for Use:
The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
A
(Division Sign-Off) Division of General Restorative Devices